- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02227836
Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis (EoE)
March 25, 2019 updated by: Karthik Ravi, M.D., Mayo Clinic
Efficacy of Allergy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study
This study is being done to see if allergy patch testing (APT) can help predict effective dietary therapy in patients with eosinophilic esophagitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients are referred to Mayo Clinic Rochester with an establish diagnosis of EoE and are nonresponsive to proton pump inhibitor (PPI) medical therapy.
Eligible patients will then meet with one of three investigators complete the Mayo Dysphagia Questionaire-30 Day (MDQ-30) following which a standardized Allergy Patch testing (APT) will be conducted.
Thereafter, a standard clinically indicated Six Food Elimination Diet treatment completed.
Patients will follow up with one of three investigators following the elimination diet who will be blinded to the results of the APT.
During this visit responders and nonresponders will be identified and nonresponders will complete a directed elimination diet based on APT results.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Adults ages 18-90
- Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field (eos per HPF) on index esophageal biopsy
- Persistent symptoms and/or greater than or equal to 10 eos per HPF on esophageal biopsy after at least 8 weeks of twice daily PPI therapy
Exclusion criteria:
- Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
- Topical swallowed steroids within 8 weeks of study enrollment
- Dermatologic conditions precluding application of Finn chambers to the skin for APT
- Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Allergy Patch Testing APT
Patient will undergo APT testing per the following protocol:
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of Patch Testing
Time Frame: up to 120 hours after application of patch test
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Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings
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up to 120 hours after application of patch test
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
August 26, 2014
First Submitted That Met QC Criteria
August 26, 2014
First Posted (Estimate)
August 28, 2014
Study Record Updates
Last Update Posted (Actual)
April 17, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-002050
- UL1TR000135 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eosinophilic Esophagitis
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Children's Hospital Medical Center, CincinnatiNational Institute of Allergy and Infectious Diseases (NIAID); National Institute... and other collaboratorsCompletedEosinophilic Esophagitis (EoE) | Eosinophilic Gastrointestinal Disorders (EGIDs)United States
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Federico II UniversityRecruitingEsophagitis, EosinophilicItaly
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Ann & Robert H Lurie Children's Hospital of ChicagoRecruitingEosinophilic Gastroenteritis | Eosinophilic Esophagitis | Eosinophilic Colitis | Eosinophilic Gastrointestinal DiseaseUnited States
-
Medical University of GrazRecruiting
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AQILION ABCompletedEosinophilic Esophagitis (EoE)United Kingdom
-
Regeneron PharmaceuticalsSanofiActive, not recruitingEosinophilic Esophagitis (EoE)United States, Canada
-
ShireTakeda Development Center Americas, Inc.TerminatedEosinophilic Esophagitis (EoE)United States
-
ShireCompletedEosinophilic Esophagitis (EoE)United States
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ShireCompleted
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ShireCompletedEosinophilic Esophagitis (EoE)United States
Clinical Trials on Allergy Patch Testing
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Hamilton Health Sciences CorporationAllerGen NCE Inc.; Food Allergy InitiativeUnknownPeanut HypersensitivityCanada
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The R2 InstituteUnknownVocal Cord Tension | Dysfluency DevelopmentalUnited States
-
Children's Mercy Hospital Kansas CityCompletedDyspepsiaUnited States
-
University Medicine GreifswaldNot yet recruitingPenicillin Allergy
-
University of MinnesotaCompletedDermatitis | Contact Dermatitis | Allergy; DermatitisUnited States
-
University of Missouri-ColumbiaWithdrawnFood Hypersensitivity | Otitis Media With EffusionUnited States
-
Centre Hospitalier Régional Metz-ThionvilleCompleted
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Tufts Medical CenterAmerican Contact Dermatitis Society (ACDS)CompletedAllergy | Dermatitis | Urticaria | Patch Testing | Contact SensitizationUnited States
-
HealthPartners InstituteRecruitingAllergic Contact DermatitisUnited States
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United States Naval Medical Center, San DiegoWithdrawnEosinophilic Esophagitis